Overview

This trial is active, not recruiting.

Conditions colorectal neoplasms, melanoma, prostatic neoplasms, renal cell carcinoma, neoplasms, patients who have/have had melanoma and other tumors
Treatment cp-675,206 (tremelimumab)
Phase phase 2
Sponsor AstraZeneca
Start date March 2008
End date December 2017
Trial size 38 participants
Trial identifier NCT00378482, A3671024, D4881C00024

Summary

This study is intended to provide access to CP-675,206 for patients who have previously received CP-675,206 in a clinical trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Drug: CP-675,206 (Tremelimumab)
cp-675,206 (tremelimumab) anti-CTLA4 human monoclonal antibody
15 mg/kg IV every 3 months as long as required

Primary Outcomes

Measure
Safety Endpoints: • Serious adverse events • Grade 3 or 4 CP-675,206-related adverse events • Immune-mediated adverse events • Hypersensitivity reactions to CP-675,206
time frame: as long as required
Efficacy Endpoints: • Tumor status: alive with disease (AWD) or no evidence of disease (NED) • Survival
time frame: as long as required

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - The subject must have already received CP-675,206 in another protocol - Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator. - Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures Exclusion Criteria:

Additional Information

Official title A Rollover Protocol For Patients Who Received CP-675,206 In Other Protocols
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.